Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781803
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-03-01
Brief Title:
Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
Study Overview
Official Title:
Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome in Outpatient Haploidentical Hematopoietic Stem Cell Transplantation
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II randomized controlled unblinded clinical trial Will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of cytokine release syndrome CRS in patients who receive an outpatient haploidentical transplant
Detailed Description:
CRS is usually limited after the administration of post-transplant cyclosporine PT-CsA administered on days 3 and 4 however there is no standard prevention or treatment regimen for CRS after haplo-TCPH and therapeutic behavior has usually been adopted
Sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center In the control group CsA 6 mgkg orally divided into two doses per day starting in the morning on day 5 of the transplant mycophenolic acid 1 gram orally 2 tablets of 500 mg from day 5 post-transplant and post-transplant cyclophosphamide PT-CY at 50 mgkg per day on days 3 and 4 and in the experimental group CsA 6 mgkg orally divided into two doses per day starting in the morning on day 0 after transplantation mycophenolic acid 1 gram orally 2 tablets 500 mg from day 0 post-transplant and PT-CY at 50 mgkg per day on day 3 and 4
Will document the presence of CRS and its degree as well as the need for hospitalization associated infectious processes and a day to recover neutrophils and platelets Additionally 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein
Sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center In the control group CsA 6 mgkg orally divided into two doses per day starting in the morning on day 5 of the transplant mycophenolic acid 1 gram orally 2 tablets of 500 mg from day 5 post-transplant and post-transplant cyclophosphamide PT-CY at 50 mgkg per day on days 3 and 4 and in the experimental group CsA 6 mgkg orally divided into two doses per day starting in the morning on day 0 after transplantation mycophenolic acid 1 gram orally 2 tablets 500 mg from day 0 post-transplant and PT-CY at 50 mgkg per day on day 3 and 4
Will document the presence of CRS and its degree as well as the need for hospitalization associated infectious processes and a day to recover neutrophils and platelets Additionally 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None